Zenas BioPharma, Inc.

Zenas BioPharma reported a net loss of $111.5 million for Q2 2026, significantly wider than the $52.2 million loss in Q2 2025. For the first six months of 2026, the net loss was $192.4 million, with revenue at $1.0 million, a decrease from $10.0 million in the prior year. The company secured new financing, including a $75.0 million senior secured term loan and $223.1 million from convertible senior notes, bolstering its cash, cash equivalents, and investments to $673.9 million as of June 30, 2026, providing at least 12 months of liquidity.

Zenas BioPharma announced that the FDA accepted its Biologics License Application (BLA) for obexelimab for the treatment of IgG4-RD, setting a PDUFA target action date of May 27, 2027. The company also appointed Christy J. Oliger to its Board of Directors, effective September 1, 2026, bringing over 30 years of biopharmaceutical commercial experience. For Q2 2026, Zenas reported a net loss of $111.5 million, an increase from $52.2 million in Q2 2025, with R&D expenses rising to $62.9 million. The company held $673.9 million in cash, cash equivalents, and investments as of June 30, 2026, and its CFO will transition to a strategic advisor role.

Zenas BioPharma announced that its Compensation Committee granted 35,750 non-qualified stock options and 79,050 restricted stock units (RSUs) to newly hired employees on July 15, 2026. These grants serve as an inducement for employment, in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price of $29.41 and vest over four years, as do the RSUs.

Zenas BioPharma, Inc. announced that its Compensation Committee granted 100,000 non-qualified stock options and 78,075 restricted stock units (RSUs) to newly hired employees on June 15, 2026. These inducement grants, made under Nasdaq Listing Rule 5635(c)(4), are intended to attract new talent. The stock options have a ten-year term with an exercise price of $18.71 and vest over four years, while the RSUs also vest in four equal installments over a four-year period.

Zenas BioPharma, a clinical-stage biopharmaceutical company specializing in autoimmune diseases, announced that its management will present at the H.C. Wainwright 7th Annual Neuro Perspectives Expert Summit. The presentation will be available on-demand starting June 15, 2026, at 7:00 a.m. ET, with a webcast and replay accessible on the company's investor relations website. Zenas is currently advancing late-stage molecules obexelimab and orelabrutinib, alongside earlier stage programs ZB021, ZB022, and ZB014.

Zenas BioPharma announced positive Phase 3 INDIGO trial results for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD), meeting its primary and all key secondary endpoints with statistical significance. The data, presented at EULAR 2026 and published in the New England Journal of Medicine, showed obexelimab significantly reduced disease flares, glucocorticoid use, and related toxicities, with a favorable safety profile. The company submitted a Biologics License Application (BLA) to the FDA in May for obexelimab in IgG4-RD. Zenas also anticipates topline results from its Phase 2 SunStone SLE trial later this year.

Zenas BioPharma announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration for obexelimab, an investigational therapy for Immunoglobulin G4-Related Disease (IgG4-RD). This submission is based on positive results from the Phase 3 INDIGO trial, where obexelimab significantly reduced the risk of IgG4-RD flare by 56% compared to placebo and met all key secondary endpoints. The company believes obexelimab could serve as a first-line therapy for long-term management of IgG4-RD, with data to be presented at the EULAR 2026 Congress. Zenas also expects to report topline results from a Phase 2 trial for Systemic Lupus Erythematosus in Q4 2026.

Zenas BioPharma announced positive safety and efficacy results from its Phase 3 INDIGO trial for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD). The trial met its primary endpoint, showing a highly statistically significant 56% reduction in IgG4-RD flare risk compared to placebo. Obexelimab also met all four key secondary endpoints and was well tolerated with no new safety signals. These results will be presented at the EULAR 2026 Congress on June 4, 2026. The company also expects topline results from a Phase 2 trial for Systemic Lupus Erythematosus in Q4 2026.

Zenas BioPharma, Inc. announced that its Compensation Committee granted an aggregate of 51,075 restricted stock units (RSUs) to newly hired employees on May 15, 2026. These grants serve as an inducement for their employment, in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest in four equal installments over a four-year period, contingent on the employees' continued service, with the first vesting occurring on May 15, 2027.

Zenas BioPharma announced the dosing of the first subject in its Phase 1 trial for ZB021, a novel potentially best-in-class oral IL-17AA/AF inhibitor. The trial will evaluate the safety, tolerability, and pharmacokinetic properties of ZB021 in healthy volunteers, with proof-of-concept in patients with plaque psoriasis. Single and multiple ascending dose data are expected by year-end 2026, and proof-of-concept data in psoriasis patients are anticipated in 2027. Zenas believes the established IL-17 mechanism may support an accelerated path toward registration-directed trials.